Mirena IUD

Mirena IUD and Pseudotumor Cerebri (PTC)

According to an April 2017 study, Mirena users were over seven times more likely to develop intracranial hypertension or pseudotumor cerebri (PTC) than other levonorgestrel intrauterine systems. Levonorgestrel is a female hormone that can cause changes in the cervix, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus. Levonorgestrel intrauterine system is a plastic device that is placed in the uterus where it slowly releases the hormone to prevent pregnancy for 3 to 5 years. Mirena is a small T-shaped plastic device inserted into the uterus that releases levonorgestrel, an artificial form of the hormone progestin. Bayer markets Mirena as “safe and effective” and “well-tolerated by patients” but, in fact, since January 1, 2004 (oldest data available in FDA database), the FDA has received 76,840 adverse event reports related to the Mirena product.

What is Idiopathic Intracranial Hypertension or Pseudotumor Cerebri (PTC)?

Pseudotumor cerebri is a disorder related to high pressure in the brain. It causes signs and symptoms of a brain tumor. The term “pseudo” means false. Pseudotumor cerebri is also called intracranial hypertension. The fluid that surrounds the spinal cord and brain is called cerebrospinal fluid or CSF. If too much fluid is produced or not enough is re-absorbed, the CSF can build up. This can cause symptoms like those of a brain tumor.

What are the symptoms of pseudotumor cerebri?

The symptoms of pseudotumor cerebri mimic those of a true brain tumor. The main sign is unusually high pressure inside the skull, known as intracranial hypertension.

Other symptoms include:

Changes in vision (like double vision)

Vision loss

Feeling dizzy or nauseated

Vomiting

Neck stiffness

Trouble walking

Frequent headaches, often along with nausea or vomiting

Persistent ringing in the ears (tinnitus)

Forgetfulness

Depression

These symptoms may look like other medical problems. Always see your healthcare provider for a diagnosis.

Diagnosis of Pseudotumor Cerebri (a/k/a Intracranial Hypertension)

Pseudotumor cerebri is generally diagnosed when doctors can’t find another reason for a series of symptoms including migraine headaches and visual disturbances. Some women may ignore the signsbbecause they believe they are merely related to menstrual cycle pain.bIn addition to Brain imaging such as MRI or CT scans, a doctor will perform a test called a lumbar puncture (also known as spinal tap). A lumbar puncture is performed in your lower back. During a lumbar puncture, a needle is inserted between two lumbar bones (vertebrae) to remove a sample of cerebrospinal fluid (“CSF”). This is the fluid that surrounds your brain and spinal cord to protect them from injury. The normal range for CSF is generally between 7-18 cm H2O in adults. However, a pressure >20 cm H2O should certainly prompt you to look for a source. Furthermore, given that levonorgestrel blood levels in women on intrauterine levonorgestrel can fluctuate at times, it is biologically plausible for a woman on Mirena to experience intracranial hypertension after only a few months of use.

If you’ve been injured by the Mirena IUD, and would like more information about current developments in the ongoing Mirena PTC litigation, please do not hesitate to contact us.